Case Study: Improving Software Implementation with Requirement Gathering Phase and Effective Business Analysis
Background
One of our recent pharmaceutical client is a large multinational corporation with multiple business units and subsidiaries. They wanted to harmonize practice and streamline the operation of their GxP Documentation by implementing a new Document Management system that could integrate all their GxP Documentation into a single platform as well as comply with FDA regulations and other industry standards to ensure the safety and efficacy of their products. The pharmaceutical company decided to partner with an IT company to design and deliver solutions that would meet their specific business requirements.
Challenge
The IT company faced a major challenge in understanding the business processes and requirements of Pharmaceutical Client due to the company’s complex organizational structure and diverse business operations.
The lack of a structured requirement-gathering process resulted in confusion and misunderstandings between the software development team and the client. As a result, the initial software solution developed did not meet the GxP requirement of the Pharmaceutical Client.
Solution
To address the challenges, software development company decided to engage Sruta Solutions as a Functional and compliance consultant for requirement gathering and effectively analyzing business requirements.
To achieve the objective of the engagement Sruta has taken the following steps:
- Workshops with End User: Conducted a series of interviews with the key stakeholders of a pharmaceutical client. to understand their business processes and requirements.
- Fit-Gap Analysis: Analyzed the existing business systems and processes of pharmaceutical client. to identify the gaps and areas for improvement.
- Documentation: Developed a comprehensive set of business requirements and specifications that captured the needs of all stakeholders.
- Prioritization: Worked collaboratively with pharmaceutical client. to prioritize the requirements and finalize the scope of the software solution.
- Software Quality Assurance: Verify the developed software against the finalized requirements before demonstrating it to the Pharmaceutical client.
Impact
The adoption of a structured approach to requirement gathering and business analysis had a significant impact on the software implementation, project timeline, software quality as well as The eleven (21 CFR Part 11 and EU Annex 11) compliance.
In detail the following benefits were realized:
A clear understanding of business requirements: The structured approach enabled the software development team to gain a clear understanding of the business requirements of the pharmaceutical client. This helped them to develop a software solution that met the specific needs of the client.
Reduced rework: The comprehensive set of business requirements and specifications minimized the chances of misunderstandings and confusion between the software development team and the client. As a result, there was a significant reduction in rework, which saved time and money for both parties.
Increased efficiency: The streamlined business processes and integrated software solution resulted in increased efficiency for a pharmaceutical client. This allowed them to focus on their core business operations and achieve their business objectives more effectively.
Conclusion
Engaging the Lifesciences Digitization experts as Functional and compliance consultants for requirement gathering and Business analysis that had a significant impact on the software implementation project for a pharmaceutical client. A clear understanding of business requirements reduced rework, improved collaboration, and increased efficiency resulting in a successful software implementation that met the specific needs of the client and achieve the best possible compliance.